510(k) · Cleared
Recalled · 2007Ammonia-Incorporating Dynamic Stabilization Technology (DST)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trace America, Inc. · JIF Enzymatic Method, Ammonia
Cleared on Jan 2, 1998 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 2, 1998
- Review
- 22 days
- Class
- Class I
- Product code
- JIF
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974620 Ammonia-Incorporating Dynamic Stabilization Technology (DST)Trace America, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK051114 Sentinel Ammonia Ultra Diagnostic AssaySentinel Ch. Srl · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051114Sentinel Ammonia Ultra Diagnostic AssaySentinel Ch. Srl · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST) | Trace America, Inc. | 1998 | — |
| +1 | K051114 | Sentinel Ammonia Ultra Diagnostic Assay | Sentinel Ch. Srl | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051114 | Sentinel Ammonia Ultra Diagnostic Assay | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2007 | Not classified | Z-0015-2008 | Device Design | Method is susceptible to positive interference from endogenous ALT in patient samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051114 (Sentinel Ch. Srl, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIF
Too few JIF 510(k)s in any year since 2007 to give a median.
Recalls per year · JIF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIF
5in 2025
MAUDE reports naming product code JIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems.
Ammonia measurements are used in the diagnosis and tredtment of severe liver disorders such as cirrhosis, hepatitus, and Reye's syndrome. " CFR 862.1065
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974620
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026